On March 7, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment (Press release, PDS Biotechnology, MAR 7, 2025, View Source [SID1234651016]).

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"We are thrilled to share that the first trial site has been initiated and activation of additional clinical sites continues," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Considering the strength and durability of the clinical responses in our VERSATILE-002 study, we are pleased to get this registrational trial underway. We are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care."

VERSATILE-003 is a global, multi-center, randomized, controlled and open-label Phase 3 pivotal trial designed to evaluate the safety and efficacy of Versamune HPV in combination with pembrolizumab as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma ("HNSCC"). The trial is designed to enroll approximately 350 patients into either the investigational arm or into a control arm receiving pembrolizumab alone at a 2:1 ratio. The primary endpoint is overall survival, and secondary endpoints include objective response rate, progression free survival, disease control rate and duration of response.
Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center will serve as the trial’s Principal Investigator.

"Advancing into Phase 3 is a significant milestone in our mission to improve treatment options for patients with HPV16-positive recurrent/metastatic HNSCC," noted Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. "We are optimistic about the potential of Versamune HPV in combination with pembrolizumab to enhance immune response and deliver meaningful clinical benefits."

Versamune HPV is an HPV-specific T cell stimulating immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways. Based on data from the VERSATILE-002 Phase 2, open-label, multicenter trial, the U.S. Food and Drug Administration granted Versamune HPV Fast Track designation, making it eligible for Priority Review at the time of Biologics License Application (BLA) submission. For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

On March 7, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that members of the RAPT management team will participate in the following investor conferences in March (Press release, RAPT Therapeutics, MAR 7, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-upcoming-investor-conferences-0 [SID1234651017]):

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Leerink Global Healthcare Conference – Fireside chat on Tuesday, March 11, 2025 at 3:40 p.m. ET
Barclays 27th Annual Global Healthcare Conference – Fireside chat on Wednesday, March 12, 2025 at 10:30 a.m. ET

To access the live webcasts or subsequent archived recordings of the discussions, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

On March 7, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the grants of inducement restricted stock units ("RSUs") to 7 new employees in connection with their employment with UroGen (Press release, UroGen Pharma, MAR 7, 2025, View Source [SID1234651018]). These new team members will support the ongoing commercialization of Jelmyto (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

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Up to 18,500 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs. The RSUs will vest equally over three years, with one-third of the underlying shares vesting each year on the anniversary of the vesting date, subject in each case to the employee’s continued service relationship with UroGen.

The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder. The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq Listing Rule 5635(c)(4).

On March 7, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the groundbreaking results of the Phase III clinical study (HARMONi-2/AK112-303) of its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, as a monotherapy compared to pembrolizumab monotherapy in the first-line treatment of PD-L1 positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) have been published in The Lancet (Press release, Akeso Biopharma, MAR 7, 2025, View Source [SID1234651020]).

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The Lancet is a prestigious international medical journal, and the publication of the HARMONi-2 study results in The Lancet is a strong recognition by the academic community to the breakthrough clinical potential of ivonescimab. Previously, clinical research on using ivonescimab for the treatment of various malignant tumors has been published in renowned international medical journals such as JAMA, Journal of Thoracic Oncology, eClinical Medicine (a sub-journal of The Lancet), and Drugs.

At the 2024 World Conference on Lung Cancer (WCLC), the results of the HARMONi-2 study were presented as an oral report by the principal investigator of the study, Professor Zhou Caicun, a renowned oncology expert who is the President-Elect of IASLC, and the director of the Department of Oncology at the Shanghai East Hospital, Tongji University.

The HARMONi-2 study demonstrated that in the intent-to-treat population, ivonescimab monotherapy significantly extended progression-free survival (PFS) compared to pembrolizumab monotherapy, reducing the risk of disease progression by 49% (PFS HR 0.51, P<0.0001). Subgroup analyses revealed that regardless of patients’ age, gender, ECOG performance status, PD-L1 expression, histological type, or the presence of liver or brain metastases, the ivonescimab group showed significant improvement in efficacy compared to the pembrolizumab group. The ivonescimab HARMONi-2 study is the world’s first randomized, double-blind, controlled Phase III clinical trial to achieve significantly positive results compared to pembrolizumab.

Based on these promising results, the sNDA for ivonescimab monotherapy as a first-line treatment for PD-L1 positive NSCLC is under review with priority status in China. Ivonescimab in combination with chemotherapy for EGFR-TKI-resistant non-squamous NSCLC, has already been approved and included in the 2024 China National Reimbursement Drug List. The growing body of clinical evidence from multiple Phase II and Phase III studies continues to validate ivonescimab’s efficacy benefit and safety profile. These results are often published in major international conferences and in top-tier journals, providing oncologists strong scientific basis for treatment decisions.

Akeso has strategically positioned ivonescimab within a comprehensive development plan, aiming to reshape the landscape of cancer immunotherapy and establish a new global standard of care. Ivonescimab, in combination with chemotherapy, has been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

Three international multicenter Phase III clinical trials, led by our partner Summit Therapeutics, are progressing efficiently or are being initiated:

The HARMONi study, an international multicenter Phase III clinical trial evaluating ivonescimab in combination with chemotherapy for non-squamous NSCLC with progression after third-generation EGFR-TKI treatment, has had patient enrollment completed and has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA),
The HARMONi-3 study, an international multicenter Phase III clinical trial comparing ivonescimab combined with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC (versus pembrolizumab combined with chemotherapy),
The HARMONi-7 study, an international multicenter Phase III clinical trial evaluating ivonescimab monotherapy as first-line treatment for PD-L1 high-expressing NSCLC (versus pembrolizumab).
Several Phase III clinical trials are progressing efficiently or are being initiated in China, including:

Ivonescimab combined with chemotherapy as first-line treatment for squamous NSCLC (vs. tislelizumab combined with chemotherapy, HARMONi-6/AK112-306),
Ivonescimab combined with chemotherapy as first-line treatment for biliary tract cancer (vs. durvalumab combined with chemotherapy, HARMONi-GI1/AK112-309),
Ivonescimab combined with AK117 (CD47) as first-line treatment for PD-L1 positive head and neck squamous cell carcinoma (vs. pembrolizumab, SOLO-10/AK117-302),
First-line treatment for triple-negative breast cancer (HARMONi-BC1/AK112-308).

On March 7, 2025 STADA, a leading healthcare and pharmaceutical company in Consumer Healthcare, Generics and Specialty pharmaceuticals, reported the company continued its profitable growth journey in 2024 (Press release, Stada, MAR 7, 2025, View Source [SID1234654338]). STADA again outperformed market sales growth in all three business segments – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. Group sales grew by 9% to € 4.059 billion versus the 2023 financial year. At the same time, earnings before interest, taxes, depreciation and amortization, adjusted for special items and currency effects, (adj. cc EBITDA) rose by 11% to € 886 million, while the adj. cc EBITDA margin increased further to 21.8%.

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"We have again in 2024 demonstrated our ability to continue growing faster than the market in all business segments. This is based on our entrepreneurial culture, our broad range of brands, our reliable production network, and the high level of trust we enjoy among our partners and customers," commented CEO Peter Goldschmidt.

STADA’s corporate culture has changed fundamentally in recent years. "At STADA, our culture drives performance. Our purpose of Caring for People’s Health as a Trusted Partner, underpinned by our values and vision, gives us a clear direction and a drive constantly to deliver ahead of the market," explained Goldschmidt. This is reflected in the outstanding results in the group’s employee survey, which in November 2024 found that 84% of employees are proud to work for STADA. As part of the evaluation by the independent Top Employers Institute, STADA was recognized as a "Top Employer 2025 Europe" for the fourth time in a row.